Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Completed · Phase 3 · Has a placebo group
Conditions studied: Fecal Incontinence
In brief
The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups: 1. placebo/usual care (educational pamphlet) 2. loperamide/usual care (educational pamphlet) 3. placebo/anal exercises with biofeedback 4. loperamide/anal exercises with biofeedback The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.
Key facts
- Study ID
- NCT02008565
- Run by
- NICHD Pelvic Floor Disorders Network
- People needed
- 300
- Starts
- 2014-02-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-11-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
You may not qualify if…
- Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale
- Current or past diagnosis of colorectal or anal malignancy
- Diagnosis of inflammatory bowel disease
- Current or history of rectovaginal fistula or cloacal defect
- Rectal prolapse (mucosal or full thickness)
- Prior removal or diversion of any portion of colon or rectum
- Prior pelvic floor or abdominal radiation
- Refusal or inability to provide written consent
- Inability to conduct telephone interviews conducted in English or Spanish
- Fecal impaction by exam
- Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond the hymen who are currently using a pessary are eligible
- Incontinence only to flatus
- Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in the last 30 days
- Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months
- Current supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- Previously received and failed treatment of fecal incontinence using supervised anal sphincter exercise/pelvic floor muscle training with biofeedback
- Previous allergy or intolerance to loperamide
- Pregnant, nursing, or planning to become pregnant before the end of the study follow-up period.
- Childbirth within the last 3 months
- Currently taking anti-retroviral drugs
- Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
- Known diagnosis of hepatic impairment
- Chronic abdominal pain in the absence of diarrhea
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of California at San Diego — La Jolla, California, United States
- Kaiser San Diego — San Diego, California, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- Duke University — Durham, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Brown/Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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